NCT02471755

Electro-acupuncture for Menopausal Transition Symptoms

A Randomized Pilot Study of Electro-acupuncture for Menopausal Transition Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: Female
• Age: 40 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This trial aimed at exploring the efficacy as well as safety of electro-acupuncture for MT symptoms.

Detailed description

This was a RCT pilot study to assess the efficacy of Electro-acupuncture for menopausal transition participants.90 patients were randomly assigned to electro-acupuncture or sham electro-acupuncture group with a ratio of 1:1.During the whole process,all participants, evaluators and statisticians apart from acupuncturists remained strictly blinded.The changes of average 24 h hot flash scores of week8 from baseline was set as primary outcome. With statistical power of 90%, and a two-sided α at 0.05, as well as a drop-out rate less than 20%, sample size was estimated at 90 participants. Data analysis was based on ITT principles, and 89 participants were included in data analysis(1 participant didn't want to participate).According to methods of LOCF, missing data were imputed to fill any gaps according to the last visit. For comparison between baseline and treatment (average 24h hot flash scores, MRS, hormone levels), data was tested by the t test or nonparametric test; for comparison between two independent samples, data were tested with t test, nonparametric test or X2 test. P\<0.05 was regarded as statistically significance.

Conditions

• Menopause

Interventions

Type	Name	Description
DEVICE	Eelectro-acupuncture	The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30\*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
DEVICE	Sham Eelectro-acupuncture	Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2015-06-15
• Last updated: 2015-11-23
• Results posted: 2015-11-23

Locations

1 site across 1 country: China